Gilead selonsertib, No safety concerns were noted

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  1. Gilead selonsertib, In Phase 2 trials for NASH, selonsertib showed promising anti-fibrotic activity, with patients improving in fibrosis stage and other liver injury measures after 24 weeks. (21,41) ASK1 is normally bound and repressed by thiol-containing antioxidant proteins, including thioredoxin 1. Oxidative stress can be increased in many pathological conditions including liver diseases such as NASH. Feb 19, 2019 · On 11 February, US-based biotech company Gilead Sciences announced that its lead non-alcoholic steatohepatitis (Nash) drug candidate, selonsertib, did not meet its primary endpoint in Stellar-4, the pivotal Phase III, placebo-controlled trial investigating its safety and effectiveness in compensated cirrhosis (F4) patients. Based on the recommendation of the Data Monitoring Committee (DMC), Gilead has terminated the studies due to lack of efficacy. 3 days ago · Selonsertib: Gilead Sciences Sotatercept: Acceleron Pharma ubenimex: Eiger BioPharmaceuticals Olaparib: AstraZeneca Further Pulmonary Arterial Hypertension product details are provided in the report. Feb 11, 2019 · About Selonsertib and the STELLAR-4 Study Selonsertib is an investigational small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress. Dec 21, 2022 · PROTOCOL SUMMARY The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD). No safety concerns were noted. Apr 25, 2019 · About Selonsertib and the STELLAR-3 Study Selonsertib is an investigational small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress. 4 days ago · Selonsertib: Gilead Sciences Sotatercept: Acceleron Pharma ubenimex: Eiger BioPharmaceuticals Olaparib: AstraZeneca Further Pulmonary Arterial Hypertension product details are provided in the report. Feb 21, 2026 · Gilead's top late-stage drug selonsertib, for patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), has failed a phase 3 trial. Feb 12, 2019 · Gilead could still revive selonsertib with positive data from an ongoing phase 3 in earlier-stage patients and a phase 2 combination study. The primary effecacy analyses were not statistically significant for either of these Phase 3 studies. Download the Pulmonary Arterial Hypertension pipeline report to learn more about the emerging Pulmonary Arterial Hypertension therapies 4 days ago · Selonsertib: Gilead Sciences Sotatercept: Acceleron Pharma ubenimex: Eiger BioPharmaceuticals Olaparib: AstraZeneca Further Pulmonary Arterial Hypertension product details are provided in the report. Cirrhosis treatment: selonsertib Specifically, neither of the . Jul 28, 2025 · Current Research and Status Gilead Sciences developed selonsertib, which progressed through Phase 2 and Phase 3 clinical trials. No further development of Selonsertib as a monotherapy in NASH is planned. Conclusions: Forty-eight weeks of selonsertib monotherapy had no antifibrotic effect in patients with bridging fibrosis or compensated cirrhosis due to NASH. The drug, an apoptosis signal-regulating A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH) Gilead Sciences, Inc. Lay summary: Patients with non-alcoholic steatohepatitis (NASH) can develop scarring of the liver (fibrosis), including cirrhosis, which increases the risks of liver failure and liver cancer. Selonsertib is a selective inhibitor of ASK1, a ubiquitously expressed serine/threonine kinase which is activated by oxidative stress to promote hepatocellular apoptosis, inflammation, and fibrosis.


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